ADVENTRX Pharmaceuticals, Inc., a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary product candidates principally for the treatment of cancer, recently provided an update on its product candidate, ANX-514, its polysorbate 80-free formulation of docetaxel. The U.S. Food and Drug Administration (FDA) determined that ANX-514 could not be approved based on the findings from the bioequivalence study of ANX-514 and that additional development activities would be required for approval. ADVENTRX met with the FDA to discuss required activities.
Prior to the meeting, ADVENTRX submitted to the FDA a data package based on Study 514-01 and published literature. ADVENTRX believes the data package supports the conclusion that comparable clinical outcomes can be expected following treatment with either ANX-514 or Taxotere, despite Study 514-01 not demonstrating bioequivalence, its primary endpoint, using an unscaled bioequivalence methodology. In particular, the data package concludes that unbound docetaxel concentrations better represent the pharmacokinetics of docetaxel and are better predictors of clinical effects and outcomes.
The FDA did not agree that evaluating bioequivalence using unbound docetaxel concentrations was warranted and determined that data from Study 514-01 was not adequate to conclude that the short period of higher exposure to total docetaxel concentrations observed early in the treatment cycle with ANX-514 do not adversely affect the safety or efficacy of ANX-514 relative to Taxotere.
“We are pleased with the outcome of our discussion with FDA, at which the conceptual design of a single, additional clinical study that could support approval of ANX-514 was discussed. We believe the study requested by the Agency is reasonable, and we are developing a study protocol for submission to the FDA. We will provide a further update after receiving feedback from FDA on the protocol,” said Brian M. Culley, Chief Executive Officer of ADVENTRX.